Low-Dose TBI and Fludarabine Followed by Unrelated Donor Stem Cell Transplantation for Patients With Hematologic Malignancies and Renal Cell Carcinoma - A Multi-Center Trial.
I. To determine whether stable allogeneic engraftment from unrelated hematopoietic stem cell
donors can be safely established using a non-myeloablative conditioning regimen in patients
with hematologic malignancies and renal cell carcinoma.
I. To evaluate whether donor lymphocyte infusion (DLI) can be safely used in patients with
mixed or full donor chimerism to eliminate persistent or progressive disease.
CONDITIONING REGIMEN: Patients receive fludarabine phosphate intravenously (IV) on days -4
to -2. Patients also undergo low-dose total-body irradiation (TBI) on day 0.
TRANSPLANTATION: Patients undergo allogeneic peripheral blood stem cell (PBSC) or bone
marrow transplantation on day 0.
IMMUNOSUPPRESSION: Patients receive cyclosporine orally (PO) twice daily (BID) on days -3 to
100 with taper to day 177 and mycophenolate mofetil PO BID on days 0-40 with taper to day
96. Patients with mixed chimerism, persistent or progressive disease, and no evidence of
graft-versus-host disease and who have been off immunosuppression for at least 2 weeks
undergo DLI over 30 minutes. DLI may be repeated every 65 days for up to 3 doses.
After completion of study treatment, patients are follow-up periodically for 5 years.
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Establishment of an allograft as defined by stable mixed chimerism or full donor chimerism
Engraftment will be assessed separately among patients who receive bone marrow and patients who receive PBSC. Patients with low-risk and high-risk disease will be assessed separately.
At day 56
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
United States: Federal Government
|Stanford University||Stanford, California 94305|
|Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium||Seattle, Washington 98109|
|University of Colorado||Denver, Colorado 80217|
|Baylor University Medical Center||Dallas, Texas 75246|
|City of Hope Medical Center||Duarte, California 91010|
|University of Utah||Salt Lake City, Utah|